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A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT00853099
Recruitment Status : Completed
First Posted : March 2, 2009
Results First Posted : November 27, 2012
Last Update Posted : September 5, 2014
Sponsor:
Collaborator:
Eisai Co., Ltd.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Interventions Biological: adalimumab
Drug: placebo
Enrollment 274
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg All Adalimumab
Hide Arm/Group Description Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
Period Title: Double-blind Period
Started 96 87 91 0
Treated 96 87 90 [1] 0
Completed Week 8 92 85 86 0
Completed 73 [2] 58 [2] 60 [2] 0
Not Completed 23 29 31 0
Reason Not Completed
Adverse Event             7             9             13             0
Withdrawal by Subject             2             3             0             0
Lack of Efficacy             14             17             16             0
Not Specified             0             0             1             0
Mistreated with rescue study drug             0             0             1             0
[1]
1 participant, incorrectly treated with open-label (rescue) study drug at Week 0, was excluded.
[2]
Participants who completed Week 52.
Period Title: Double-blind + Open-label Periods
Started 0 0 0 266 [1]
Completed 0 0 0 119
Not Completed 0 0 0 147
Reason Not Completed
Lack of Efficacy             0             0             0             74
Adverse Event             0             0             0             47
Withdrawal by Subject             0             0             0             20
Not Specified             0             0             0             6
[1]
7 participants randomized to placebo did not receive any adalimumab; 1 participant was excluded.
Arm/Group Title Placebo Adalimumab 80 mg/40 mg Adalimumab 160 mg/80 mg Total
Hide Arm/Group Description Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. Total of all reporting groups
Overall Number of Baseline Participants 96 87 90 273
Hide Baseline Analysis Population Description
1 participant in the adalimumab 160 mg/80 mg arm was incorrectly treated with open-label (rescue) study drug at Week 0, and was not included in Baseline Characteristics.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 96 participants 87 participants 90 participants 273 participants
41.3  (13.56) 44.4  (15.04) 42.5  (14.56) 42.7  (14.38)
[1]
Measure Description: Demographic data are provided for the Full Analysis Set (participants who received at least one dose of study drug in the double-blind portion of the study).
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 87 participants 90 participants 273 participants
Female
26
  27.1%
37
  42.5%
29
  32.2%
92
  33.7%
Male
70
  72.9%
50
  57.5%
61
  67.8%
181
  66.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 96 participants 87 participants 90 participants 273 participants
96 87 90 273
Mayo score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 96 participants 87 participants 90 participants 273 participants
8.5  (1.56) 8.5  (1.42) 8.6  (1.44) 8.5  (1.47)
[1]
Measure Description:

A composite score of ulcerative colitis disease activity calculated as the sum of 4 subscores:

  • Stool frequency, based on the participant's diary, scored from 0 (normal number of stools) to 3 (≥5 stools than normal);
  • Rectal bleeding, based on the participant's diary, scored from 0 (no blood) to 3 (blood only passed);
  • Endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration);
  • Physician's Global Assessment, scored from 0 (normal) to 3 (severe disease). The total Mayo score ranges from 0 to 12; higher scores indicate more severe disease.
1.Primary Outcome
Title Percentage of Participants With Clinical Remission at 8 Weeks
Hide Description

Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:

  • Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);
  • Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed);
  • Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);
  • Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).

The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease.

Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set includes all patients who received at least 1 dose of study drug any time during the first 52 weeks and with at least 1 efficacy measurement after the first dose of study medication. Non-responder imputation (NRI) was used, where all missing values and values after the start of rescue treatment were considered non-remission.
Arm/Group Title Placebo Adalimumab 80 mg/40 mg Adalimumab 160 mg/80 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Overall Number of Participants Analyzed 96 87 90
Measure Type: Number
Unit of Measure: percentage of participants
11.5 13.8 10.0
2.Primary Outcome
Title Percentage of Participants With Clinical Remission at 52 Weeks
Hide Description

Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:

  • Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);
  • Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed);
  • Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);
  • Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).

The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease.

Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. Non-responder imputation (NRI) was used, where all missing remission values and values after the start of rescue treatment were considered as non-remission.
Arm/Group Title Placebo Adalimumab 80 mg/40 mg Adalimumab 160 mg/80 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Overall Number of Participants Analyzed 96 87 90
Measure Type: Number
Unit of Measure: percentage of participants
7.3 26.4 20.0
3.Secondary Outcome
Title Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks
Hide Description

Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:

  • Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);
  • Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed);
  • Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scores from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);
  • Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).

The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease.

Time Frame Weeks 8, 32, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, non-responder imputation was used.
Arm/Group Title Placebo Adalimumab 80 mg/40 mg Adalimumab 160 mg/80 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Overall Number of Participants Analyzed 96 87 90
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 11.5 13.8 10.0
Week 32 8.3 17.2 17.8
Week 52 7.3 26.4 20.0
4.Secondary Outcome
Title Percentage of Participants With a Clinical Response
Hide Description

A clinical response was defined as a decrease in Mayo score of ≥ 3 points and ≥ 30% from Baseline PLUS a decrease in the Rectal Bleeding Subscore (RBS) ≥ 1 or an absolute RBS of 0 or 1.

The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:

  • Stool Frequency Subscore, based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal);
  • Rectal Bleeding Subscore, based on the participant's diary and scored from zero (no blood) to three (blood only passed);
  • Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration);
  • Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease).

The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease.

Time Frame Baseline and Weeks 8, 32, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, non-responder imputation was used.
Arm/Group Title Placebo Adalimumab 80 mg/40 mg Adalimumab 160 mg/80 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Overall Number of Participants Analyzed 96 87 90
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 35.4 42.5 50.0
Week 32 20.8 33.3 37.8
Week 52 17.7 29.9 31.1
5.Secondary Outcome
Title Percentage of Participants With Mucosal Healing
Hide Description

Mucosal healing was defined as an endoscopy subscore of ≤ 1 and was assessed using flexible sigmoidoscopy performed at Weeks 8, 32, and 52.

The endoscopy subscore ranges from zero to three as follows:

0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration).

Time Frame Weeks 8, 32, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, non-responder imputation was used.
Arm/Group Title Placebo Adalimumab 80 mg/40 mg Adalimumab 160 mg/80 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Overall Number of Participants Analyzed 96 87 90
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 30.2 39.1 44.4
Week 32 21.9 27.6 31.1
Week 52 15.6 28.7 28.9
6.Secondary Outcome
Title Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1)
Hide Description

Rectal bleeding was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The rectal bleeding subscore ranges from zero to three, according to the following scale:

0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed.

Time Frame Weeks 8, 32, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, non-responder imputation was used.
Arm/Group Title Placebo Adalimumab 80 mg/40 mg Adalimumab 160 mg/80 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Overall Number of Participants Analyzed 96 87 90
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 67.7 80.5 71.1
Week 32 28.1 40.2 43.3
Week 52 22.9 32.2 34.4
7.Secondary Outcome
Title Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1)
Hide Description

The Physician's Global Assessment Subscore acknowledges the three other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the participant's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the participant's performance status. Possible scores range from zero to three as follows:

0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3).

Time Frame Weeks 8, 32, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, non-responder imputation was used.
Arm/Group Title Placebo Adalimumab 80 mg/40 mg Adalimumab 160 mg/80 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Overall Number of Participants Analyzed 96 87 90
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 44.8 47.1 61.1
Week 32 28.1 36.8 37.8
Week 52 19.8 29.9 34.4
8.Secondary Outcome
Title Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1)
Hide Description

Stool frequency was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The stool frequency subscore ranges from zero to three, according to the following scale:

0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal.

Time Frame Weeks 8, 32, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, non-responder imputation was used.
Arm/Group Title Placebo Adalimumab 80 mg/40 mg Adalimumab 160 mg/80 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Overall Number of Participants Analyzed 96 87 90
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 32.3 34.5 40.0
Week 32 20.8 33.3 31.1
Week 52 13.5 28.7 28.9
9.Secondary Outcome
Title Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders
Hide Description An inflammatory bowel disease questionnaire responder was defined as a participant with at least a 16-point increase from Baseline in total Inflammatory Bowel Disease Questionnaire (IBDQ) score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with the total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).
Time Frame Baseline and Weeks 8, 32, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set, non-responder imputation was used.
Arm/Group Title Placebo Adalimumab 80 mg/40 mg Adalimumab 160 mg/80 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Overall Number of Participants Analyzed 96 87 90
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 39.6 48.3 42.2
Week 32 21.9 33.3 28.9
Week 52 12.5 29.9 21.1
10.Secondary Outcome
Title Number of Participants With Adverse Events up to Week 8
Hide Description

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.

A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

For more details on adverse events please see the Adverse Event section below.

Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set includes all participants who received at least one dose of study medication.
Arm/Group Title Placebo Adalimumab 80 mg/40 mg Adalimumab 160 mg/80 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Overall Number of Participants Analyzed 96 87 90
Measure Type: Number
Unit of Measure: participants
Any adverse event 45 49 40
Any AE at least possibly drug related 10 14 12
Any serious adverse event 7 2 4
Any AE leading to discontinuation of study drug 4 0 6
11.Secondary Outcome
Title Number of Participants With Adverse Events up to Week 52
Hide Description

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.

A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

For more details on adverse events please see the Adverse Event section below.

Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set.
Arm/Group Title Placebo Adalimumab 80 mg/40 mg Adalimumab 160 mg/80 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
Overall Number of Participants Analyzed 96 87 90
Measure Type: Number
Unit of Measure: participants
Any adverse event 67 68 75
Any AE at least possibly drug related 17 23 32
Any serious adverse event 12 14 10
Any AE leading to discontinuation of study drug 5 5 12
12.Secondary Outcome
Title Number of Participants With Adverse Events During the Adalimumab Treatment Period
Hide Description

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.

A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

For more details on adverse events please see the Adverse Event section below.

Time Frame 221 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set.
Arm/Group Title All Adalimumab
Hide Arm/Group Description:
All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
Overall Number of Participants Analyzed 266
Measure Type: Number
Unit of Measure: participants
Any adverse event 261
Any AE at least possibly drug related 142
Any serious adverse event 90
Any AE leading to discontinuation of study drug 37
Time Frame For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug.
Adverse Event Reporting Description Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
 
Arm/Group Title Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg All Adalimumab
Hide Arm/Group Description Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
All-Cause Mortality
Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg All Adalimumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg All Adalimumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/96 (13.54%)   14/87 (16.09%)   10/90 (11.11%)   90/266 (33.83%) 
Cardiac disorders         
ATRIAL FLUTTER  1  0/96 (0.00%)  0/87 (0.00%)  1/90 (1.11%)  1/266 (0.38%) 
PERICARDITIS  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
SUPRAVENTRICULAR TACHYCARDIA  1  0/96 (0.00%)  0/87 (0.00%)  1/90 (1.11%)  1/266 (0.38%) 
VENTRICULAR TACHYCARDIA  1  1/96 (1.04%)  0/87 (0.00%)  0/90 (0.00%)  0/266 (0.00%) 
Ear and labyrinth disorders         
SUDDEN HEARING LOSS  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
Eye disorders         
DIABETIC RETINOPATHY  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
Gastrointestinal disorders         
COLITIS ULCERATIVE  1  8/96 (8.33%)  5/87 (5.75%)  5/90 (5.56%)  38/266 (14.29%) 
COLONIC POLYP  1  0/96 (0.00%)  1/87 (1.15%)  0/90 (0.00%)  3/266 (1.13%) 
ENTEROCOLITIS  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
GASTROINTESTINAL DYSPLASIA  1  0/96 (0.00%)  0/87 (0.00%)  1/90 (1.11%)  3/266 (1.13%) 
INTESTINAL POLYP  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
PANCREATITIS ACUTE  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
RECTAL STENOSIS  1  1/96 (1.04%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
RECTAL ULCER HAEMORRHAGE  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
STOMATITIS  1  1/96 (1.04%)  0/87 (0.00%)  0/90 (0.00%)  0/266 (0.00%) 
General disorders         
ADVERSE DRUG REACTION  1  0/96 (0.00%)  1/87 (1.15%)  0/90 (0.00%)  1/266 (0.38%) 
DEATH  1  0/96 (0.00%)  0/87 (0.00%)  1/90 (1.11%)  1/266 (0.38%) 
DRUG INTOLERANCE  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
FATIGUE  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
MALAISE  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  2/266 (0.75%) 
Hepatobiliary disorders         
CHOLECYSTITIS  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  2/266 (0.75%) 
CHOLELITHIASIS  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
Infections and infestations         
APPENDICITIS  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
BACTERIAL INFECTION  1  1/96 (1.04%)  0/87 (0.00%)  0/90 (0.00%)  0/266 (0.00%) 
BRONCHITIS  1  0/96 (0.00%)  1/87 (1.15%)  1/90 (1.11%)  2/266 (0.75%) 
BURSITIS INFECTIVE  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
CYTOMEGALOVIRUS INFECTION  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
ENTERITIS INFECTIOUS  1  1/96 (1.04%)  0/87 (0.00%)  0/90 (0.00%)  2/266 (0.75%) 
ERYSIPELAS  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
GASTROENTERITIS  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  2/266 (0.75%) 
GASTROINTESTINAL INFECTION  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
GINGIVITIS  1  0/96 (0.00%)  0/87 (0.00%)  1/90 (1.11%)  1/266 (0.38%) 
INFECTION  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
PELVIC ABSCESS  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
PNEUMONIA  1  0/96 (0.00%)  0/87 (0.00%)  1/90 (1.11%)  1/266 (0.38%) 
PNEUMONIA BACTERIAL  1  0/96 (0.00%)  1/87 (1.15%)  1/90 (1.11%)  3/266 (1.13%) 
PSEUDOMEMBRANOUS COLITIS  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
PYELONEPHRITIS ACUTE  1  0/96 (0.00%)  1/87 (1.15%)  0/90 (0.00%)  2/266 (0.75%) 
TUBERCULOSIS  1  0/96 (0.00%)  0/87 (0.00%)  1/90 (1.11%)  1/266 (0.38%) 
UPPER RESPIRATORY TRACT INFECTION  1  0/96 (0.00%)  0/87 (0.00%)  1/90 (1.11%)  1/266 (0.38%) 
Injury, poisoning and procedural complications         
HAND FRACTURE  1  0/96 (0.00%)  1/87 (1.15%)  0/90 (0.00%)  1/266 (0.38%) 
HEAT ILLNESS  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  2/266 (0.75%) 
INTENTIONAL OVERDOSE  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
LIGAMENT INJURY  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
WOUND  1  0/96 (0.00%)  1/87 (1.15%)  0/90 (0.00%)  1/266 (0.38%) 
Investigations         
DRUG LEVEL  1  0/96 (0.00%)  1/87 (1.15%)  0/90 (0.00%)  1/266 (0.38%) 
MEDICAL OBSERVATION  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  3/266 (1.13%) 
Metabolism and nutrition disorders         
DECREASED APPETITE  1  1/96 (1.04%)  0/87 (0.00%)  0/90 (0.00%)  0/266 (0.00%) 
DIABETES MELLITUS  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  2/266 (0.75%) 
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  0/96 (0.00%)  1/87 (1.15%)  0/90 (0.00%)  1/266 (0.38%) 
JOINT RANGE OF MOTION DECREASED  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
MUSCLE HAEMORRHAGE  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
OSTEONECROSIS  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
PERIARTHRITIS  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
ROTATOR CUFF SYNDROME  1  0/96 (0.00%)  1/87 (1.15%)  0/90 (0.00%)  1/266 (0.38%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
BREAST CANCER  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
CERVIX CARCINOMA  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
PANCREATIC CARCINOMA  1  0/96 (0.00%)  0/87 (0.00%)  1/90 (1.11%)  1/266 (0.38%) 
PARATHYROID TUMOUR  1  0/96 (0.00%)  1/87 (1.15%)  0/90 (0.00%)  1/266 (0.38%) 
RECTAL CANCER  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  3/266 (1.13%) 
THYROID CANCER  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
UTERINE LEIOMYOMA  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  2/266 (0.75%) 
Nervous system disorders         
CEREBRAL HAEMORRHAGE  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
EPILEPSY  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
NEUROPATHY PERIPHERAL  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
Psychiatric disorders         
DEPRESSION  1  1/96 (1.04%)  1/87 (1.15%)  0/90 (0.00%)  1/266 (0.38%) 
Renal and urinary disorders         
CALCULUS URETERIC  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
NEPHROLITHIASIS  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
TUBULOINTERSTITIAL NEPHRITIS  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
Reproductive system and breast disorders         
CERVICAL DYSPLASIA  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
Skin and subcutaneous tissue disorders         
ERYTHEMA NODOSUM  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
Surgical and medical procedures         
IMMUNOSUPPRESSANT DRUG THERAPY  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
Vascular disorders         
TAKAYASU'S ARTERITIS  1  0/96 (0.00%)  0/87 (0.00%)  0/90 (0.00%)  1/266 (0.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Double-blind Placebo Double-blind Adalimumab 80 mg/40 mg Double-blind Adalimumab 160 mg/80 mg All Adalimumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   51/96 (53.13%)   47/87 (54.02%)   60/90 (66.67%)   235/266 (88.35%) 
Blood and lymphatic system disorders         
IRON DEFICIENCY ANAEMIA  1  7/96 (7.29%)  4/87 (4.60%)  8/90 (8.89%)  24/266 (9.02%) 
Gastrointestinal disorders         
COLITIS ULCERATIVE  1  5/96 (5.21%)  2/87 (2.30%)  5/90 (5.56%)  20/266 (7.52%) 
DENTAL CARIES  1  5/96 (5.21%)  6/87 (6.90%)  3/90 (3.33%)  27/266 (10.15%) 
NAUSEA  1  4/96 (4.17%)  2/87 (2.30%)  5/90 (5.56%)  26/266 (9.77%) 
STOMATITIS  1  1/96 (1.04%)  0/87 (0.00%)  1/90 (1.11%)  14/266 (5.26%) 
VOMITING  1  1/96 (1.04%)  0/87 (0.00%)  4/90 (4.44%)  23/266 (8.65%) 
General disorders         
INJECTION SITE REACTION  1  2/96 (2.08%)  7/87 (8.05%)  6/90 (6.67%)  25/266 (9.40%) 
MALAISE  1  0/96 (0.00%)  3/87 (3.45%)  7/90 (7.78%)  13/266 (4.89%) 
PYREXIA  1  4/96 (4.17%)  4/87 (4.60%)  5/90 (5.56%)  24/266 (9.02%) 
Hepatobiliary disorders         
HEPATIC FUNCTION ABNORMAL  1  0/96 (0.00%)  1/87 (1.15%)  1/90 (1.11%)  14/266 (5.26%) 
Infections and infestations         
GASTROENTERITIS  1  1/96 (1.04%)  0/87 (0.00%)  2/90 (2.22%)  16/266 (6.02%) 
INFLUENZA  1  6/96 (6.25%)  3/87 (3.45%)  4/90 (4.44%)  20/266 (7.52%) 
NASOPHARYNGITIS  1  21/96 (21.88%)  19/87 (21.84%)  30/90 (33.33%)  162/266 (60.90%) 
ORAL HERPES  1  0/96 (0.00%)  1/87 (1.15%)  0/90 (0.00%)  14/266 (5.26%) 
PHARYNGITIS  1  2/96 (2.08%)  1/87 (1.15%)  1/90 (1.11%)  15/266 (5.64%) 
Investigations         
WHITE BLOOD CELL COUNT DECREASED  1  2/96 (2.08%)  3/87 (3.45%)  6/90 (6.67%)  22/266 (8.27%) 
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  1/96 (1.04%)  5/87 (5.75%)  2/90 (2.22%)  21/266 (7.89%) 
BACK PAIN  1  3/96 (3.13%)  3/87 (3.45%)  4/90 (4.44%)  31/266 (11.65%) 
Nervous system disorders         
HEADACHE  1  6/96 (6.25%)  3/87 (3.45%)  7/90 (7.78%)  42/266 (15.79%) 
Psychiatric disorders         
INSOMNIA  1  2/96 (2.08%)  2/87 (2.30%)  3/90 (3.33%)  23/266 (8.65%) 
Respiratory, thoracic and mediastinal disorders         
OROPHARYNGEAL PAIN  1  2/96 (2.08%)  0/87 (0.00%)  2/90 (2.22%)  23/266 (8.65%) 
UPPER RESPIRATORY TRACT INFLAMMATION  1  4/96 (4.17%)  3/87 (3.45%)  5/90 (5.56%)  27/266 (10.15%) 
Skin and subcutaneous tissue disorders         
ECZEMA  1  2/96 (2.08%)  4/87 (4.60%)  1/90 (1.11%)  27/266 (10.15%) 
RASH  1  5/96 (5.21%)  4/87 (4.60%)  3/90 (3.33%)  27/266 (10.15%) 
Vascular disorders         
HYPERTENSION  1  2/96 (2.08%)  1/87 (1.15%)  1/90 (1.11%)  15/266 (5.64%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00853099     History of Changes
Other Study ID Numbers: M10-447
First Submitted: February 27, 2009
First Posted: March 2, 2009
Results First Submitted: October 26, 2012
Results First Posted: November 27, 2012
Last Update Posted: September 5, 2014